NCT05929768ClinicalTrials.gov
Shorter Chemo-Immunotherapy Without Anthracycline Drugs for Early-Stage Triple Negative Breast Cancer
Shorter Anthracycline-Free Chemo Immunotherapy Adapted to Pathological Response in Early Triple Negative Breast Cancer (SCARLET), A Randomized Phase III Study
باختصار
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from…
المرحلة 3مطلوب 2,400 مشارك963 موقعاً3 دول
الفئات
مسجَّلة في سجل واحد
- ClinicalTrials.govNCT05929768فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين
يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.
تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.
هل أنت مهتم بهذه الدراسة؟
تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.
How this study is set up
The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.
- Present: Registered before enrolment beganFirst posted 2023-07-03; recorded start 2023-09-15
- Present: Has a defined primary outcomeA primary outcome measure is listed in the record
- Present: The primary outcome states a time frameThe primary outcome measure records a time frame
- Present: Participants are randomly assignedAllocation is recorded as randomised
- Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
- Not stated: Open label (no blinding)Masking is recorded as none (open label)
- Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
- Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
- Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
- Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
- Present: Sponsor has 72 other studies in this databaseCounted from the lead sponsor named in the record (SWOG Cancer Research Network)
- Present: Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
- The record lists 5 conditions.
- Lead sponsor type recorded as: research network.
- Intervention regulatory context: investigational, within a phased regulatory pathway.
Trial stature
Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.
A strong methodological design for a phase 3 study, judged from its ClinicalTrials.gov record.
How this score is built
- Randomised allocation20/20
Participants are randomly allocated between arms
- Blinding0/20
Open-label
- Control arm15/15
Active-comparator control arm
- Primary-outcome specificity10/10
Named primary outcome with a defined time frame
- Endpoint type10/10
Mortality / MACE endpoint (hard clinical outcome)
- Multi-centre8/8
Multi-centre: 963 sites
- Data monitoring committee7/7
A data monitoring committee is in place
- Prospective registration5/5
Registered before the study start date
- Protocol / SAP posted0/5
No protocol or SAP posted to the registry
A large study, international in scope: 2,400 participants (target), run at 963 sites, across 3 countries.
How this score is built
- Enrolment34/40
2,400 participants (target)
- Site count25/25
963 sites
- Country count7/15
3 countries
- Planned duration10/10
Planned over about 116 months
- Sponsor scale7/10
SWOG Cancer Research Network has led 72 trials in our corpus
We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.
How this score is built
- Investigator standing0/100
No investigator recorded in the registry for this trial
These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.
ملخص
This phase III trial compares the effects of shorter chemotherapy (chemo)-immunotherapy without anthracyclines to usual chemo-immunotherapy for the treatment of early-stage triple negative breast cancer. Paclitaxel is in a class of medications called anti-microtubule agents. It stops cancer cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Doxorubicin is an anthracycline chemotherapy drug that damages DNA and may kill cancer cells. Pembrolizumab may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Shorter treatment without anthracycline chemotherapy may work the same as the usual anthracycline chemotherapy treatment for early-stage triple negative breast cancer.
الحالات
- Anatomic Stage I Breast Cancer AJCC v8
- Anatomic Stage II Breast Cancer AJCC v8
- Anatomic Stage IIIA Breast Cancer AJCC v8
- Anatomic Stage IIIB Breast Cancer AJCC v8
- Early Stage Triple-Negative Breast Carcinoma
الأهلية
| الجنس | الجميع |
|---|---|
| الأعمار | 18 Years – لا حد أقصى |
| المتطوعون الأصحّاء | لا |
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | تدخّلية |
|---|---|
| المرحلة | المرحلة 3 |
| التخصيص | معشّاة |
| نموذج التدخّل | PARALLEL |
| الغرض الأساسي | TREATMENT |
| التعمية | NONE (0) |
| التجنيد | مطلوب 2,400 مشارك |
الجهة الراعية والمتعاونون
- SWOG Cancer Research Network الجهة الراعية
- National Cancer Institute (NCI) المتعاونون
الأذرع والتدخلات
- Arm I (usual chemo-immunotherapy)ACTIVE_COMPARATOR
Patients receive paclitaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then receive doxorubicin IV, cyclophosphamide IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.
- Arm II (shorter chemo-immunotherapy)EXPERIMENTAL
Patients receive docetaxel IV, carboplatin IV, and pembrolizumab IV on study. Patients then undergo surgery. Patients may receive pembrolizumab after surgery. Patients may optionally undergo collection of blood samples throughout the trial.
التدخلات
- إجراء Biospecimen Collection
Undergo collection of blood samples
- دواء Carboplatin
Given IV
- دواء Cyclophosphamide
Given IV
- دواء Docetaxel
Given IV
- دواء Doxorubicin
Given IV
- دواء Paclitaxel
Given IV
- منتج بيولوجي Pembrolizumab
Given IV
- أخرى Quality-of-Life Assessment
Ancillary studies
- أخرى Questionnaire Administration
Ancillary studies
- إجراء Surgical Procedure
Undergo surgery
مقاييس النتائج
مقياس النتيجة الأولي
Breast cancer event-free survival (BC-EFS)
Time from randomization to the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause. New non-breast primaries are not included as events. BC-EFS will be compared between the treatment arms using Cox regression with adjustment for nodal status and sTIL enrichment.
الإطار الزمني Up to 5 years
مقياس النتيجة الثانوي
Pathologic complete response (pCR)
pCR rates by assigned treatment arm will be compared using a difference of two proportions overall and by stromal tumor infiltrating lymphocytes (sTIL) group. Additionally, a multivariable logistic regression model will estimate the odds ratio for treatment adjusting for nodal status and sTIL group.
الإطار الزمني From date of randomization to date of the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause, assessed up to 5 years
مقياس النتيجة الثانوي
Residual cancer burden (RCB)
RCB 0/I rates (i.e., RCB-0 and RCB-I combined) by assigned treatment arm will be compared using a difference of two proportions overall and by sTIL group. Additionally, a multivariable logistic regression model will estimate the odds ratio for treatment adjusting for nodal status and sTIL group.
الإطار الزمني Up to 5 years
مقياس النتيجة الثانوي
Distant relapse-free survival (DRFS)
DRFS will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status.
الإطار الزمني From date of randomization to date of invasive distant disease recurrence or death due to any cause, assessed up to 5 years
مقياس النتيجة الثانوي
Overall survival (OS)
OS will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status.
الإطار الزمني From date of randomization to date of death due to any cause, assessed up to 5 years
مقياس النتيجة الثانوي
Distant relapse-free interval (DRFI)
DRFI will be compared by treatment arms using Cox regression for treatment adjusted by nodal status and sTIL status. Deaths not due to breast cancer will be considered competing risks in this analysis. Cumulative incidence curves will describe the two arms over the follow-up period from randomization.
الإطار الزمني From date of randomization to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years
مقياس النتيجة الثانوي
Relapse free survival (RFS)
RFS measured from time of surgery will compare treatment arms in a Cox regression for patients who had pCR. Nodal status and sTIL status will be included as covariates if there are sufficient numbers of events for the analysis. The expectation is that invasive breast cancer-free survival after pCR should not differ by treatment assignment.
الإطار الزمني From time of surgery to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years
مقياس النتيجة الثانوي
RFS
RFS measured from time of surgery will compare treatment arms in a Cox regression for patients who did not have a pCR. Nodal status and sTIL status will be included as covariates.
الإطار الزمني From time of surgery to date of invasive distant disease recurrence or death due to breast cancer or its treatment, assessed up to 5 years
مقياس النتيجة الثانوي
Incidence of adverse events
Rates of adverse events will be compared between treatment arms for those initiating the assigned therapy.
الإطار الزمني Up to 5 years
مقياس النتيجة الثانوي
Patient-Reported Fatigue
Participant-reported fatigue will be compared between treatment arms using the Participant-Reported Outcomes Measurement Information System (PROMIS) Short Form v1.0 - Fatigue 7a at 3 weeks after the last neoadjuvant systemic therapy dose and at 18 months after randomization. The PROMIS Fatigue-7a is a validated 7-item questionnaire that assesses participant-reported fatigue in the past 7 days. Raw scores are converted to T-scores with a mean of 50 and a standard deviation of 10. Higher T-scores indicate more fatigue.
الإطار الزمني Up to 18 months
مقياس النتيجة الثانوي
Patient-Reported Physical Function
Participant-reported physical function will be compared between treatment arms using the PROMIS-29 Profile v2.1 physical function subscale score at 3-5 weeks after the last neoadjuvant systemic therapy dose. The PROMIS-29 Profile is a validated 29-item questionnaire that assesses participant-reported symptoms in 9 domains. Raw scores for each subscale are converted to T-scores with a mean of 50 and a standard deviation of 10. This outcome will be assessed using the 4-item physical functioning subscale. Higher T-scores indicate greater physical function.
الإطار الزمني Up to 5 weeks after the last neoadjuvant systemic therapy dose
مقياس النتيجة الثانوي
Patient-Reported Physical Function
Participant-reported physical function will be compared between treatment arms using the PROMIS-29 Profile v2.1 physical function subscale score at 18 months after randomization. The PROMIS-29 Profile is a validated 29-item questionnaire that assesses participant-reported symptoms in 9 domains. Raw scores for each subscale are converted to T-scores with a mean of 50 and a standard deviation of 10. This outcome will be assessed using the 4-item physical functioning subscale. Higher T-scores indicate greater physical function.
الإطار الزمني Up to 18 months
التواريخ
| تاريخ البدء | 15 سبتمبر 2023 (فعلي) |
|---|---|
| الإتمام الأولي | 31 مارس 2033 (تقديري) |
| الإتمام | 1 أبريل 2033 (تقديري) |
| أول نشر | 3 يوليو 2023 (فعلي) |
| آخر تحديث | 5 نوفمبر 2025 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | نوفمبر 2025 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
923 موقعاً قيد التجنيد
Mexico
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Instituto Nacional De Cancerologia de Mexico | Mexico City | Tlalpan | قيد التجنيد |
Puerto Rico
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Puerto Rico Hematology Oncology Group | Bayamón | قيد التجنيد | |
| Cancer Center-Metro Medical Center Bayamon | Bayamón | قيد التجنيد | |
| Doctors Cancer Center | Manati | قيد التجنيد | |
| PROncology | San Juan | قيد التجنيد | |
| San Juan Community Oncology Group | San Juan | قيد التجنيد | |
| San Juan City Hospital | San Juan | قيد التجنيد | |
| Centro Comprensivo de Cancer de UPR | San Juan | قيد التجنيد |
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| UM Upper Chesapeake Hematology and Oncology - Aberdeen | Aberdeen | Maryland | قيد التجنيد |
| Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | قيد التجنيد |
| Hickman Cancer Center | Adrian | Michigan | مُعلَّق |
| Riverwood Healthcare Center | Aitkin | Minnesota | قيد التجنيد |
| Summa Health System - Akron Campus | Akron | Ohio | قيد التجنيد |
| Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | قيد التجنيد |
| Aultman Alliance Community Hospital | Alliance | Ohio | قيد التجنيد |
| MyMichigan Medical Center Gratiot | Alma | Michigan | قيد التجنيد |
| MyMichigan Medical Center Alpena | Alpena | Michigan | قيد التجنيد |
| OSF Saint Anthony's Health Center | Alton | Illinois | قيد التجنيد |
| McFarland Clinic - Ames | Ames | Iowa | قيد التجنيد |
| Mary Greeley Medical Center | Ames | Iowa | قيد التجنيد |
| Community Hospital of Anaconda | Anaconda | Montana | قيد التجنيد |
| Kaiser Permanente-Anaheim | Anaheim | California | قيد التجنيد |
| Alaska Breast Care and Surgery LLC | Anchorage | Alaska | قيد التجنيد |
| Katmai Oncology Group | Anchorage | Alaska | قيد التجنيد |
| Providence Alaska Medical Center | Anchorage | Alaska | قيد التجنيد |
| Anchorage Oncology Centre | Anchorage | Alaska | مُعلَّق |
| Anchorage Radiation Therapy Center | Anchorage | Alaska | مُعلَّق |
| Alaska Oncology and Hematology LLC | Anchorage | Alaska | قيد التجنيد |
| Anchorage Associates in Radiation Medicine | Anchorage | Alaska | قيد التجنيد |
| Alaska Women's Cancer Care | Anchorage | Alaska | قيد التجنيد |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | قيد التجنيد |
| Trinity Health Saint Joseph Mercy Hospital Ann Arbor | Ann Arbor | Michigan | قيد التجنيد |
| University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | قيد التجنيد |
| Luminis Health Anne Arundel Medical Center | Annapolis | Maryland | نشط، دون تجنيد |
| Langlade Hospital and Cancer Center | Antigo | Wisconsin | قيد التجنيد |
| Ascension Saint Elizabeth Hospital | Appleton | Wisconsin | قيد التجنيد |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | قيد التجنيد |
| Mission Hope Medical Oncology - Arroyo Grande | Arroyo Grande | California | قيد التجنيد |
| PCR Oncology | Arroyo Grande | California | قيد التجنيد |
| Cone Health MedCenter Asheboro | Asheboro | North Carolina | قيد التجنيد |
| Cone Health Cancer Center at Asheboro | Asheboro | North Carolina | مُعلَّق |
| AdventHealth Infusion Center Asheville | Asheville | North Carolina | قيد التجنيد |
| Duluth Clinic Ashland | Ashland | Wisconsin | قيد التجنيد |
| Northwest Wisconsin Cancer Center | Ashland | Wisconsin | قيد التجنيد |
| Grady Health System | Atlanta | Georgia | قيد التجنيد |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | قيد التجنيد |
| Emory University Hospital/Winship Cancer Institute | Atlanta | Georgia | قيد التجنيد |
| Emory University Hospital Midtown | Atlanta | Georgia | قيد التجنيد |
| Sutter Cancer Centers Radiation Oncology Services-Auburn | Auburn | California | قيد التجنيد |
| Sutter Auburn Faith Hospital | Auburn | California | قيد التجنيد |
يُدرَج 913 موقعاً إضافياً في سجل السجل.
مستندات الدراسة
لا تُرتبط أي مستندات في سجل السجل هذا.
التغيّرات عبر الزمن
لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.
يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.